Implementing a real-time PCR-based method for sterility release testing of ATMPs
22 February 2023
3:00pm
Shares
- Like
- Digg
- Del
- Tumblr
- VKontakte
- Flattr
- Buffer
- Love This
- Odnoklassniki
- Meneame
- Blogger
- Amazon
- Yahoo Mail
- Gmail
- AOL
- Newsvine
- HackerNews
- Evernote
- MySpace
- Mail.ru
- Viadeo
- Line
- Comments
- Yummly
- SMS
- Viber
- Telegram
- Subscribe
- Skype
- Facebook Messenger
- Kakao
- LiveJournal
- Yammer
- Edgar
- Fintel
- Mix
- Instapaper
- Copy Link
Join this webinar presented by Dr Miriam Dormeyer and Yasmin Heynen, as they discuss rapid sterility testing for ATMPs using a real-time PCR-based method and how this method can be implemented in a GMP cleanroom class A.
About this webinar
Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, the requirements for real-time measurement and the testing of cell-containing products cannot be met with most of these methods.
In contrast, the real-time polymerase chain reaction (PCR) methodology offers a sterility test on cellular products with determination of the results on the same day. The required detection limit of < 100 CFU according to USP <1071> can be met.
A particular challenge here lies in the implementation of the molecular biological method in a multi-room Grade A cleanroom environment. Practical implementation of the technique, considering the possible risk factors will be presented.
Key takeaways
- Understand how real-time PCR can be implemented as sterility testing method for ATMPs
- Discover how Yasmin Heynen designed the setup and risk analysis for the implementation of the rapid sterility testing in a cleanroom class A
- Learn about the validation strategy at Sartorius including the authorities’ requirements for rapid microbiological methods
- Ask the experts questions about this process and benefit from their knowledge and guidance during the live event.